Indian Regulatory Update: January-March 2015

This document provides updates in regulatory requirements regarding conduct of clinical trials in India.

AMENDED COMPENSATION RULES - GSR 889 (E) RELEASED

• Central Drugs Standard Control Organisation (CDSCO) has issued amended compensation rules providing more clarity on the definition of the term “related to clinical trials (CT)”

• Clarifications provided for serious adverse event (SAE) reporting timelines to specify that in case of SAE not reported within 24 h of occurrence, the investigator needs to provide reasons for the same

• Notification also provides better clarity on various other aspects of the compensation rules, the gazette notification can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/Notificatiohn%20on%20Compensation%20on%20clincial%20trial%20(1).pdf.

DRAFT DRUGS AND COSMETICS (AMENDMENT) BILL, 2015

• Draft Drugs and Cosmetics (Amendment) bill 2015 has been released for public comments

• The bill makes the provision for CT under Drugs and Cosmetics Act

• Provisions also made for import, manufacture, and CT with devices

• The bill also makes the provisions for CT with cosmetics

• Penalties have been proposed for various offences like conduct of CT without permission from licensing authority and Expert Committee (EC), violation of conditions of clinical trial permission, not providing compensation, etc

• Bill makes the provisions for appeal mechanisms for parties aggrieved by the orders under the amended act as well

• Complete draft of the bill can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/D and %20C%20AMMENDMENT%20BILL%281%29.pdf.

DRUGS AND COSMETICS (THIRD AMENDMENT) RULES 2015

• Draft amendment of D and C rules as per GSR 69(E) has been released by CDSCO

• The amendment omits Rule 122DAA which defines a clinical trial, and the definition of clinical trial has been provided as part of the explanation to Rule 122DA

• The amendment also defines certain terms such as global clinical trial (GCT), IND, and new chemical entity (NCE) as part of the explanation to Rule 122DA along with definition of CT

• Amendment makes the provision for providing information regarding “assessment of risk versus benefit to patients,” “innovation vis-à-vis existing therapeutic option,” and “unmet medical need in the country” mandatory as part of form 44 and Appendix I of Schedule Y

• Draft notification can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/G_S_R_%2069(E).pdf.

DRAFT STANDARDS AND APPLICATION FORMAT FOR ACCREDITATION OF ETHICS COMMITTEE, INVESTIGATOR AND CLINICAL TRIAL SITE

• CDSCO has issued draft standards for accreditation of EC and sites as per recommendations of an EC under the Chairmanship of Prof. Ranjit Roy Chaudhury

• The Ministry of Health and Family Welfare decided to assign the job of accreditation to Quality Council of India

• The Accreditation Standards and format for application for Accreditation prepared by Quality Council of India are uploaded on CDSCO website for comments/suggestions of stakeholders

• Accreditation standards and formats can be accessed at following URL: http://cdsco.nic.in/forms/list.aspx?lid=2074 and Id=23.

PRESUBMISSION MEETINGS PROPOSED TO BE INITIATED BY CENTRAL DRUGS STANDARD CONTROL ORGANISATION

• CDSCO has decided to introduce a system of formal Presubmission Meetings of applicants with CDSCO officers and subject experts to discuss regulatory pathway in respect of specific application for approval of clinical trial, new drug, medical device etc

• The system will facilitate to understand the regulatory pathways required to be followed by the applicants for approvals resulting in bringing transparency, accountability, predictability, and speedy disposal of cases

• Notice inviting comments for the proposal was issued by CDSCO, the same can be accessed at following URL: http://www.cdsco.nic.in/writereaddata/NOTICE15.pdf.